Evaluation of Pacemaker Algorithms to Avoid Unnecessary Right Ventricular Pacing (ADVANTAGE)

April 7, 2017 updated by: Deutsches Herzzentrum Muenchen

AV-Hysteresis Versus Mode Switch to AAI (MVP) for the Avoidance of Unnecessary Right Ventricular Pacing

Unnecessary right ventricular pacing has been shown to be detrimental in recipients of implantable pacemaker or defibrillators.

The ADVANTAGE study evaluates the efficacy of two pacemaker based algorithms (atrioventricular hysteresis function versus mode switch to atrial pacing) to reduce right ventricular pacing.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

Comparison of the effect of an atrioventricular hysteresis function with a mode switch to atrial pacing on the right ventricular pacing percentage in a multi-centre, prospective, randomized, single blinded, cross-over study.

Study Type

Interventional

Enrollment (Actual)

70

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Germany
    • Bayern
      • Bamberg, Bayern, Germany, 96049
        • Klinikum Bamberg
      • München, Bayern, Germany, 80636
        • Deutsches Herzzentrum München, Klinik für Herz- und Kreislauferkrankungen
      • Peißenberg, Bayern, Germany, 82380
        • Krankenhaus Peißenberg

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

Indication for the implantation of a dual-chamber pacemaker

Exclusion Criteria:

Persistent or permanent atrial tachyarrhythmias atrioventricular block 2nd or 3rd degree indication or the implantation of an defibrillator

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Crossover Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: mode switch to atrial pacing
Other: pacemaker programming to mode switch to atrial pacing versus atrioventricular hysteresis function
Active Comparator: atrioventricular hysteresis function
Other: pacemaker programming to mode switch to atrial pacing versus atrioventricular hysteresis function

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Right ventricular pacing percentage
Time Frame: 3 months
3 months

Secondary Outcome Measures

Outcome Measure
Time Frame
BNP levels
Time Frame: 3 months
3 months

Other Outcome Measures

Outcome Measure
Time Frame
Occurrence of atrial tachyarrhythmias
Time Frame: 3 months
3 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Deutsches Herzzentrum Muenchen

Collaborators

Medtronic
Klinikum Bamberg
Krankenhaus Peißenberg

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

November 1, 2007

Primary Completion (Actual)

December 1, 2011

Study Completion (Actual)

June 1, 2016

Study Registration Dates

First Submitted

February 28, 2013

First Submitted That Met QC Criteria

March 1, 2013

First Posted (Estimate)

March 4, 2013

Study Record Updates

Last Update Posted (Actual)

April 10, 2017

Last Update Submitted That Met QC Criteria

April 7, 2017

Last Verified

April 1, 2017

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • GER-EP-010

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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